Pharmacodynamic Effects of Sacubitril/Valsartan on Natriuretic Peptides, Angiotensin and Neprilysin

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-16

Study Completion Date

2022-05-31

Brief Summary

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The study measure multiple neurohormones in patients with heart failure being treated with Sacubitril/Valsartan in increasing doses over an 8 week period.

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Detailed Description

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Conditions

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Heart Failure, Systolic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

Increasing doses of Sacubitril/Valsartan

Group Type EXPERIMENTAL

Sacubitril / Valsartan Oral Tablet

Intervention Type DRUG

Increasing doses of Sacubitril/Valsartan

Interventions

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Sacubitril / Valsartan Oral Tablet

Increasing doses of Sacubitril/Valsartan

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Patients must give written informed consent before any study assessment is performed.
2. Ambulatory ≥ 18 years of age, male or female, treated at Ringerike Hospital.
3. Patients with symptomatic chronic heart failure and reduced ejection fraction (≤ 40%).
4. Patients on optimized medical treatment for heart failure. -

Exclusion Criteria

1. Patients not able to comply in the study.
2. Patients having contraindication for treatment with Entresto;

1. Hypersensitivity to the active substances or to any of the excipients listed in section
2. Hyperkalemia: \> 5.4 mmol/L
3. Known history of angioedema related to previous ACE inhibitor or ARB therapy.
4. Hereditary or idiopathic angioedema.
5. Concomitant use with Aliskiren-containing medicinal products in patients with diabetes mellitus or in patients with renal impairment (eGFR \<60 ml/min/1.73m2)
6. End-stage renal disease (\<15 mL/min per 1.73m2 or treatment by dialysis).
7. Severe hepatic impairment, biliary cirrhosis and cholestasis (Child-Pugh C classification).
8. Pregnancy Breast-feeding-

Eligible Sex

ALL

Accepts Healthy Volunteers

No